Development of Novel MRI Methods for Detecting, Discriminating, and Measuring Liver Fibrosis and Congestion in Fontan Patients

Terminated

• Conditions: Liver Fibrosis
• Interventions: Device: Non-Contrast Magnetic Resonance Imaging

• Registration Number: NCT03539757
• Lead Sponsor: Children's Hospital Medical Center, Cincinnati

Brief Summary

In this research study, the investigators will conduct a prospective cross-sectional study of pediatric and adult Fontan patients that will correlate a variety of quantitative MRI biomarkers with histopathologic data.

Detailed Description

The purpose of this study is to develop noninvasive MRI methods for detecting, discriminating, and measuring liver fibrosis and congestion in the adolescent and adult Fontan population by correlating quantitative imaging measurements with histopathologic data, using a cross-sectional approach.

Over 5 years, approximately 40 pediatric and adult subjects (approximately 8 subjects per year) undergoing clinically-indicated liver biopsy for the evaluation of either 1) focal liver lesions/masses, or 2) suspected liver fibrosis/parenchymal disease will be recruited to participate in this study. Subjects will undergo research MR imaging within ±2 weeks of the liver biopsy procedure. A variety of MRI biomarkers will be correlated with histopathologic data obtained from the clinically indicated liver biopsy.

Study Timeline

• Study Start: 2018-05-09
• Study First Submitted: 2018-05-16
• Study First Submitted QC: 2018-05-16
• Study First Posted: 2018-05-29
• Status Verified: 2021-06
• Primary Completion: 2022-03-30
• Study Completion: 2022-03-30
• Last Update Submitted: 2024-03-05
• Last Update Posted: 2024-03-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

• Single ventricle physiology congenital heart disease status post Fontan palliation
• Undergoing clinically-indicated liver biopsy
• Ability to tolerate 60 minutes in an MRI scanner without sedation

Exclusion Criteria

• Known contraindication to MR imaging (e.g., implanted non-MRI compatible device)
• Known or suspected pregnancy. Female subjects of child bearing potential will undergo urine pregnancy testing prior to imaging

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Fontan patients	Non-Contrast Magnetic Resonance Imaging	Pediatric and adult Fontan patients will undergo MRI (Magnetic Resonance Imaging) of the liver using novel, non-contrast MRI methods. These MR methods will be used to detect, discriminate and measure liver fibrosis and congestion. The resulting quantitative imaging measurements will be correlated with histopathologic data obtained from a clinically-indicated liver biopsy.

Primary Outcome Measures

Name	Time	Method
MR elastography data correlation to histologic data	60 minutes	MR elastography of the liver data will be correlated with histopathologic data obtained from non-lesional liver tissue. Histologic fibrosis and congestion will be scored by a pathologist using semi-quantitative grading systems (e.g., METAVIR scoring system for fibrosis

Secondary Outcome Measures

Name	Time	Method
MR T1rho data correlation to histologic data	60 minutes	MR T1rho liver data will be correlated with histopathologic data obtained from non-lesional liver tissue. Histologic fibrosis and congestion will be scored by a pathologist using semi-quantitative grading systems (e.g., METAVIR scoring system for fibrosis)
MR T1 mapping data (corrected and uncorrected) correlation to histologic data	60 minutes	MR T1 mapping liver data (corrected and uncorrected) will be correlated with histopathologic data obtained from non-lesional liver tissue. Histologic fibrosis and congestion will be scored by a pathologist using semi-quantitative grading systems (e.g., METAVIR scoring system for fibrosis)
MR T2 mapping data correlation to histologic data	60 minutes	MR T2 mapping liver data will be correlated with histopathologic data obtained from non-lesional liver tissue. Histologic fibrosis and congestion will be scored by a pathologist using semi-quantitative grading systems (e.g., METAVIR scoring system for fibrosis)
MR Diffusion weighted data correlation to histologic data	60 minutes	MR Diffusion weighted liver data will be correlated with histopathologic data obtained from non-lesional liver tissue. Histologic fibrosis and congestion will be scored by a pathologist using semi-quantitative grading systems (e.g., METAVIR scoring system for fibrosis)

Trial Locations

Locations (1)

Cincinnati Children's Hospital Medical Center; 🇺🇸 Cincinnati, Ohio, United States